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Comparison of Image-Guided Iodine-125 Seed Interstitial Brachytherapy and Local Chemotherapy Perfusion in Treatment of Advanced Pancreatic Cancer.
Zhou, L, Yang, H, Xie, L, Sun, J, Qian, J, Zhu, L
Journal of investigative surgery : the official journal of the Academy of Surgical Research. 2022;(1):1-6
Abstract
OBJECTIVE To compare the efficacy and safety of iodine-125 seed interstitial brachytherapy and local chemotherapy perfusion in treatment of advanced pancreatic cancer. METHODS The present open prospective randomized control study included a total of 165 cases of advanced pancreatic cancer patients who were admitted in our hospital during December 2016 to April 2019. All patients were randomized into two groups with 84 cases in iodine-125 group and 81 cases in chemotherapy perfusion group. Basic clinical characteristics and demographic data were collected. The main outcome was the tumor efficiency. The pain condition was measured by visual analogue scale (VAS) and the Karnofsky score was also measured at different time points, before the treatment, 1 d, 7 d, 14 d, 1 mon, 2 mon and 3 mon after treatment. Serum levels of CEA, CA19-9 and CA50 were measured by immunochemiluminescence. The overall survival was analyzed by K-M curve. RESULTS The ratio of partial remission patients was significantly higher, and the ratio of stable disease (SD)+progressive disease patients was also remarkably lower in iodine-125 group than the chemotherapy perfusion group. The mean VAS scores decreased markedly after treatment and were significantly lower and the mean Karnofsky scores were remarkably higher in iodine-125 group than the chemotherapy perfusion group. The levels of CA19-9 and CA50 were remarkably lower in iodine-125 group, however no significant difference was found for CEA. The survival analysis by K-M curve showed the iodine-125 patients had longer overall survival time than the chemotherapy perfusion group. No infection, pancreatic fistula, biliary fistula, intestinal fistula, gastrointestinal obstruction or radiation enteritis was found in both groups. CONCLUSION Iodine-125 seed interstitial brachytherapy could achieve better efficacy with no increased side complications than chemotherapy perfusion in advanced pancreatic cancer.
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A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer.
Brose, MS, Panaseykin, Y, Konda, B, de la Fouchardiere, C, Hughes, BGM, Gianoukakis, AG, Joo Park, Y, Romanov, I, Krzyzanowska, MK, Leboulleux, S, et al
The Journal of clinical endocrinology and metabolism. 2022;(3):776-787
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Abstract
BACKGROUND Lenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differentiated thyroid cancer (RR-DTC) at a starting dose of 24 mg/day. This study explored, in a double-blinded fashion, whether a starting dose of 18 mg/day would provide comparable efficacy with reduced toxicity. METHODS Patients with RR-DTC were randomized to lenvatinib 24 mg/day or 18 mg/day. The primary efficacy endpoint was objective response rate as of week 24 (ORRwk24); the odds ratio noninferiority margin was 0.4. The primary safety endpoint was frequency of grade ≥3 treatment-emergent adverse events (TEAEs) as of week 24. Tumors were assessed using RECIST v1.1. TEAEs were monitored and recorded. RESULTS The ORRwk24 was 57.3% (95% CI 46.1, 68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3, 51.2) in the lenvatinib 18-mg arm, with an odds ratio (18/24 mg) of 0.50 (95% CI 0.26, 0.96). As of week 24, the rates of TEAEs grade ≥3 were 61.3% in the lenvatinib 24-mg arm and 57.1% in the lenvatinib 18-mg arm, a difference of -4.2% (95% CI -19.8, 11.4). CONCLUSION A starting dose of lenvatinib 18 mg/day did not demonstrate noninferiority compared to a starting dose of 24 mg/day as assessed by ORRwk24 in patients with RR-DTC. The results represent a clinically meaningful difference in ORRwk24. The safety profile was comparable, with no clinically relevant difference between arms. These results support the continued use of the approved starting dose of lenvatinib 24 mg/day in patients with RR-DTC and adjusting the dose as necessary.
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Does Radioactive Iodine Therapy for Hyperthyroidism Cause Cancer?
Kim, BW
The Journal of clinical endocrinology and metabolism. 2022;(2):e448-e457
Abstract
Radioactive iodine has been considered a safe and effective therapeutic option for hyperthyroidism secondary to Graves disease and autonomously functioning thyroid nodules since the mid-20th century. The question of whether I-131 at the doses used for hyperthyroidism might increase the risk of cancer has been investigated in a number of observational cohort studies over the years, with the preponderance of evidence being reassuring as to its safety. In particular, the 1998 Cooperative Thyrotoxicosis Therapy Follow-up Study (CTTFUS) has been widely cited as compelling evidence that I-131 is safe in hyperthyroidism therapy with respect to carcinogenesis. However, in 2019, a study by Kitahara and colleagues re-analyzed the CTTFUS cohort, extending the follow-up time and applying a novel dosimetric model for estimating tissue absorbed doses of radiation. This new analysis concluded that radioactive iodine was associated with an increased risk for mortality from overall cancer, breast cancer, and non-breast solid cancers. Reaction to this study was vociferous and particularly negative in the nuclear medicine literature. This mini-review was inspired by the 2019 CTTFUS controversy, and it is intended to provide the necessary context for clinicians to provide nuanced advice to their patients on the subject. To that end, the pre-2019 literature is surveyed, the 2019 CTTFUS study and a 2020 follow-up are discussed, and lessons from the literature and critical commentaries are considered.
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Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer.
Leboulleux, S, Bournaud, C, Chougnet, CN, Zerdoud, S, Al Ghuzlan, A, Catargi, B, Do Cao, C, Kelly, A, Barge, ML, Lacroix, L, et al
The New England journal of medicine. 2022;(10):923-932
Abstract
BACKGROUND In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits. METHODS In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization. RESULTS Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of -0.3 percentage points (two-sided 90% CI, -2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported. CONCLUSIONS In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years. (Funded by the French National Cancer Institute; ESTIMABL2 ClinicalTrials.gov number, NCT01837745.).
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The efficacy and safety of Iodine-131-metaiodobenzylguanidine therapy in patients with neuroblastoma: a meta-analysis.
He, H, Xu, Q, Yu, C
BMC cancer. 2022;(1):216
Abstract
OBJECTIVE Neuroblastoma is a common extracranial solid tumor of childhood. Recently, multiple treatments have been practiced including Iodine-131-metaiodobenzylguanidine radiation (131I-MIBG) therapy. However, the outcomes of efficacy and safety vary greatly among different studies. The aim of this meta-analysis is to evaluate the efficacy and safety of 131I-MIBG in the treatment of neuroblastoma and to provide evidence and hints for clinical decision-making. METHODS Medline, EMBASE database and the Cochrane Library were searched for relevant studies. Eligible studies utilizing 131I-MIBG in the treatment of neuroblastoma were included. The pooled outcomes (response rates, adverse events rates, survival rates) were calculated using either a random-effects model or a fixed-effects model considering of the heterogeneity. RESULTS A total of 26 clinical trials including 883 patients were analyzed. The pooled rates of objective response, stable disease, progressive disease, and minor response of 131I-MIBG monotherapy were 39%, 31%, 22% and 15%, respectively. The pooled objective response rate of 131I-MIBG in combination with other therapies was 28%. The pooled 1-year survival and 5-year survival rates were 64% and 32%. The pooled occurrence rates of thrombocytopenia and neutropenia in MIBG monotherapy studies were 53% and 58%. In the studies of 131I-MIBG combined with other therapies, the pooled occurrence rates of thrombocytopenia and neutropenia were 79% and 78%. CONCLUSION 131I-MIBG treatment alone or in combination of other therapies is effective on clinical outcomes in the treatment of neuroblastoma, individualized 131I-MIBG is recommended on a clinical basis.
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Long-term efficacy and safety of chemotherapy-free first-line iodine-131-rituximab radioimmunotherapy of follicular lymphoma.
Kesavan, M, Zammar, G, McQuillan, JT, Macdonald, WBG, Turner, JH, McQuillan, AD
British journal of haematology. 2022;(1):237-241
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Low-Iodine Diet of 4 Days Is Sufficient Preparation for 131I Therapy in Differentiated Thyroid Cancer Patients.
Dekker, BL, Links, MH, Muller Kobold, AC, Swart-Busscher, LG, Kars, M, Bons, JAP, Brouwers, AH, Links, TP, van der Horst-Schrivers, ANA
The Journal of clinical endocrinology and metabolism. 2022;(2):e604-e611
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Abstract
CONTEXT No consensus exists about the optimal duration of the low-iodine diet (LID) in the preparation of 131I therapy in differentiated thyroid cancer (DTC) patients. OBJECTIVE This work aimed to investigate if a LID of 4 days is enough to achieve adequate iodine depletion in preparation for 131I therapy. In addition, the nutritional status of the LID was evaluated. METHODS In this prospective study, 65 DTC patients treated at 2 university medical centers were included between 2018 and 2021. The patients collected 24-hour urine on days 4 and 7 of the LID and kept a food diary before and during the LID. The primary outcome was the difference between the 24-hour urinary iodine excretion (UIE) on both days. RESULTS The median 24-hour UIE on days 4 and 7 of the LID were not significantly different (36.1 mcg [interquartile range, 25.4-51.2 mcg] and 36.5 mcg [interquartile range, 23.9-47.7 mcg], respectively, P = .43). On day 4 of the LID, 72.1% of the DTC patients were adequately prepared (24-hour UIE < 50 mcg), and 82.0% of the DTC patients on day 7 (P = .18). Compared to the self-reported regular diet, DTC patients showed a significantly (P < .01) lower percentage of nutrient intake (calories, protein, calcium, iodine, and water) during the LID. CONCLUSION The 24-hour UIE on day 4 of the LID did not differ from day 7, and therefore shortening the LID from 7 to 4 days seems justified to prepare DTC patients for 131I therapy in areas with sufficient iodine intake and may be beneficial to maintain a sufficient nutritional intake during DTC treatment.
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Cancer Risk After Radioactive Iodine Treatment for Hyperthyroidism: A Systematic Review and Meta-analysis.
Shim, SR, Kitahara, CM, Cha, ES, Kim, SJ, Bang, YJ, Lee, WJ
JAMA network open. 2021;(9):e2125072
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IMPORTANCE Whether radioactive iodine (RAI) therapy for hyperthyroidism can increase cancer risk remains a controversial issue in medicine and public health. OBJECTIVES To examine site-specific cancer incidence and mortality and to evaluate the radiation dose-response association after RAI treatment for hyperthyroidism. DATA SOURCES The Medline and Cochrane Library electronic databases, using the Medical Subject Headings terms and text keywords, and Embase, using Emtree, were screened up to October 2020. STUDY SELECTION Study inclusion criteria were as follows: (1) inclusion of patients treated for hyperthyroidism with RAI and followed up until cancer diagnosis or death, (2) inclusion of at least 1 comparison group composed of individuals unexposed to RAI treatment (eg, the general population or patients treated for hyperthyroidism with thyroidectomy or antithyroid drugs) or those exposed to different administered doses of RAI, and (3) inclusion of effect size measures (ie, standardized incidence ratio [SIR], standardized mortality ratio [SMR], hazard ratio [HR], or risk ratio [RR]). DATA EXTRACTION AND SYNTHESIS Two independent investigators extracted data according to the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Overall quality assessment followed the recommendations of United Nations Scientific Committee on the Effects of Atomic Radiation. The SIR and SMRs and the RRs and HRs were pooled using random-effects meta-analysis. MAIN OUTCOMES AND MEASURES Cancer incidence and mortality for exposure vs nonexposure to RAI therapy and by level of RAI administered activity. RESULTS Based on data from 12 studies including 479 452 participants, the overall pooled cancer incidence ratio was 1.02 (95% CI, 0.95-1.09) and the pooled cancer mortality ratio was 0.98 (95% CI, 0.92-1.04) for exposure vs nonexposure to RAI therapy. No statistically significant elevations in risk were observed for specific cancers except thyroid cancer incidence (SIR, 1.86; 95% CI, 1.19-2.92) and mortality (SMR, 2.22; 95% CI, 1.37-3.59). However, inability to control for confounding by indication and other sources of bias were important limitations of studies comparing RAI exposure with nonexposure. In dose-response analysis, RAI was significantly associated with breast and solid cancer mortality (breast cancer mortality, per 370 MBq: 1.35; P = .03; solid cancer mortality, per 370 MBq: 1.14; P = .01), based on 2 studies. CONCLUSIONS AND RELEVANCE In this meta-analysis, the overall pooled cancer risk after exposure to RAI therapy vs nonexposure was not significant, whereas a linear dose-response association between RAI therapy and solid cancer mortality was observed. These findings suggest that radiation-induced cancer risks following RAI therapy for hyperthyroidism are small and, in observational studies, may only be detectable at higher levels of administered dose.
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Clinical analysis of 125I seed implantation combined with epidermal growth factor receptor-tyrosine kinase inhibitors in advanced non-small cell lung cancer.
Wang, X, Wang, D
Journal of B.U.ON. : official journal of the Balkan Union of Oncology. 2021;(5):1879-1886
Abstract
PURPOSE To explore the efficacy and safety of 125I radioactive seed implantation combined with epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in the treatment of advanced non-small cell lung cancer (NSCLC). METHODS 108 patients with EGFR mutation-positive unresectable advanced NSCLC (stage IIIB-IV) were randomly divided into 125I group (treated with 125I radioactive seed implantation combined with EGFR-TKIs, n=54) and EGFR-TKIs group (treated with EGFR-TKIs alone, n=54). The short-term efficacy and adverse reactions were analyzed and evaluated, the changes in the levels of peripheral blood T lymphocyte subsets, natural killer (NK) cells and related immune-inflammatory factors were analyzed, and the long-term survival and progression of disease were recorded. RESULTS The objective response rate was 61.1% (33/54) and 51.9% (28/54), and the disease control rate was 88.9% (48/54) and 68.5% (37/54), respectively, in 125I group and EGFR-TKIs group. At 6 months after treatment, the levels of peripheral blood cluster of differentiation 3+ (CD3+), CD4+, CD4+/CD8+ and NK cells significantly rose in both groups compared with those before treatment (p<0.05), while the levels of CD8+, serum tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), interleukin-6 (IL-6) and IL-10 significantly declined compared with those before treatment. The 2-year overall survival (OS) rate was 53.7% (29/54) and 40.7% (22/54), and the median progression-free survival (PFS) was 14.5 months and 9.8 months, respectively, in 125I group and EGFR-TKIs group. CONCLUSIONS 125I radioactive seed implantation combined with EGFR-TKIs is safe and effective in the treatment of advanced NSCLC, and its short-term efficacy and long-term survival rate of patients are significantly superior to those of EGFR-TKIs alone. At the same time, it can regulate the expressions of T lymphocyte subsets, NK cells and immune-inflammatory factors in patients, and improve their immune function.
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131I-metaiodobenzylguanidine and peptide receptor radionuclide therapy in pheochromocytoma and paraganglioma.
Jungels, C, Karfis, I
Current opinion in oncology. 2021;(1):33-39
Abstract
PURPOSE OF REVIEW Pheochromocytomas and paragangliomas are rare tumors arising, respectively, from the adrenal medulla and extra-adrenal sympathetic or parasympathetic paraganglia. The main therapeutic objectives in case of metastatic disease are the reduction of tumor burden and the control of symptoms resulting from excessive catecholamine secretion. Treatment choices constitute not only a wait and see attitude, locoregional approaches, chemotherapy regiments but also radiopharmaceutical agents, and they should be discussed in a specialized multidisciplinary board. This review will briefly discuss the radiopharmaceutical modalities in patients with pheochromocytomas and paragangliomas (I-MIBG and PRRT). RECENT FINDINGS I-MIBG (Azedra) has received FDA approval for patients with iobenguane-scan-positive, unresectable, locally advanced or metastatic pheochromocytomas and paragangliomas who require systemic anticancer therapy, whereas peptide receptor radionuclide therapy using radiolabelled somatostatin analogues is currently performed in compassionate use, with very promising results. No prospective head-to-head comparison between the modalities has been conducted to date. SUMMARY Promising results have been reported for both radiopharmaceutical agents, mostly in the setting of retrospective series. No prospective head-to-head comparison between the modalities is yet available.